Last updated: 11/03/2018 10:22:08
Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer
GSK study ID
109117
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer
Trial description: The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer
Timeframe: Average time frame: 6-12 months
Occurrence of any of the human papillomavirus types (human papillomavirus-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with squamous cell carcinoma
Timeframe: Average time frame: 6-12 months
Secondary outcomes:
Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer
Timeframe: Average time frame:6-12 months
Interventions:
Procedure/surgery: Collection of cervical cancer tissue samples
Other: Data collection
Enrollment:
591
Observational study model:
Case-Only
Primary completion date:
2010-31-03
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Infections, Papillomavirus, Cervical Cancer
Product
SB580299
Collaborators
University of Cape Town, African Organization for Research and Training in Cancer (AORTIC)
Study date(s)
October 2007 to March 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
21+ years
Accepts healthy volunteers
No
- * A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer.
- * Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- * A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer. * Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date. * Written or oral-witnessed informed consent obtained from the subject prior to any study procedure. * No prior chemo- or radiotherapy for cervical cancer.
Exclusion criteria:
- Not applicable
Trial location(s)
Location
GSK Investigational Site
Observatory, Western Province, South Africa, 7935
Status
Study Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2010-31-03
Actual study completion date
2010-31-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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